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Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease

NCT02013791 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2018-05-15

Study results available
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Summary

This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Vehicle

Vehicle of cyclosporine administered as per protocol

OTHER

Sham

Sham administered to non-study eye as per protocol on Day 1

DRUG

Cyclosporine New Ophthalmic Formulation

Cyclosporine New Ophthalmic Formulation administered as per protocol

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Eleonora Safyan · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-29
Primary Completion
2017-04-12
Completion
2017-04-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02013791 on ClinicalTrials.gov